‘On’ time improvement significant at day 3 with combination therapy for Parkinson’s

Key takeaways:

• Data showed significant improvements in daily Unified Parkinson’s Disease Rating Scale motor scores.
• By day 7, the proportion of participants with full morning “on” time increased from 31.6% to 72.2%.

Improvements in “on” time were observed as early as day 3 after treatment initiation with an investigational subcutaneous combination therapy for Parkinson’s disease, which also led to significant improvement by day 7, data show.

“(The study) centered around providing Parkinson’s disease patients with more ‘on’ time without troublesome dyskinesia,” Nelson Lopes, MD, PharmD, senior medical director of clinical development at NeuroDerm, told Healio in an email regarding the data, which were presented at the Congress of the European Academy of Neurology.

Primary results from this phase 2 study demonstrated that 28 days of treatment with 24 hours of subcutaneous levodopa/carbidopa infusion with the investigational therapeutic, ND0612 increased “good on” time with either no dyskinesia or a mild form of the condition by a least-squares mean of 3.7 hours (P < 0.001) in levodopa- treated patients with PD experiencing motor fluctuations.

Lopes and colleague Fabrizio Stocchi, MD, PhD, a consultant with NeuroDerm, sought to report data from a secondary analysis that evaluated the onset of efficacy for the 24-hour ND0612 regimen (n = 19) as related by both study participants and clinicians.

The 28-day, open- label study featured individuals diagnosed with PD who registered at least 2.5 hours per day of “off” time despite optimized treatment. Participants were administered a 24-hour-long infusion and received a daily levodopa/carbidopa dose of 720 mg/90 mg plus oral levodopa/carbidopa as adjunctive therapy when required.

According to results, on day 3, 73.7% of patients reported improvements in their global impression of health.

Lopes and Stocchi also reported that by day 3, the treatment resulted in significant improvements compared with baseline in daily “good on” time as well as “on” time with moderate-to-severe dyskinesia.

Data further showed improvements in Unified Parkinson’s Disease Rating Scale motor scores in the morning (reduction from 37.4 to 26.6 at 8 a.m.; from 28.3 to 19.2 at 4 p.m.), while, at day 7, Lopes and Stocchi reported that the proportion of patients who reported achieving a full “on” at 9 a.m. increased from 31.6% at baseline to 72.2%.

“Our results demonstrated that significant and clinically relevant improvement in ‘on’ time can be seen as soon as day 3 after beginning treatment,” Lopes told Healio.